Identity
- Trade Name
- Otinova EUDAMED
- Device Name
- Otinova EUDAMED
- Model / Reference
- 92514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350133960560 EUDAMED
- Basic UDI-DI
- 735013396Otinova1QC EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Otinova by Circius Pharma AB — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 735013396Otinova1QC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Circius Pharma AB
- EUDAMED SRN
- SE-MF-000013023
Sources (1)
- EUDAMED 93a04834-9b87-4844-9e02-6af15c4e74d6 61 fields · synced Jun 18, 2026